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The Use of Low Level Laser Therapy for Wound Healing in Leprosy Patients

Primary Purpose

Leprosy

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Routine treatment

Low level laser therapy (LLLT)

About this trial

This is an interventional treatment trial for Leprosy focused on measuring Leprosy, Ulcers, Laser

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

presented with neuropathic ulcer
attended at least 3 weekly appointments at the dressing service of UREMC
completed specific multi-drug therapy for M. leprae
gave written informed consent to participate in the study

Exclusion Criteria:

clinically detectable infection in the ulcer
use of drugs, like corticosteroids that could interfere with the wound healing process
use of special dressings like hydrocolloid, calcium alginate, activated carbon or any kind of therapeutic procedure different from that used routinely for both groups of study
non-attendance to therapeutic program (six sequential times or nine intercalated)
pregnancy
discomfort during treatment procedure

Sites / Locations

Dr. Marcello Candia Reference Unit in Sanitary Dermatology of the State of Pará in Brazil (UREMC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

Subjects from the arm number 1 received routine treatment, including daily simple dressings with sterile gauze after wound cleaning with a 0.9% physiologic solution, use of 1% hydrophilic silver sulfadiazine cream (Prati Donaduzzi Laboratory, Toledo, Brazil) and orientation about the use of adapted footwear, self-care and the prevention of disabilities. Surgical debridement was done whenever indicated by nursing or orthopedic services from UREMC.

Subjects from the arm number 2 received low level laser therapy 3 times per week for 12 weeks, in addition to the same treatment as patients from the arm number 1.

Outcomes

Primary Outcome Measures

Wound healing

Secondary Outcome Measures

Ulcer surface area, depth and PUSH tool score.

Full Information

NCT ID

NCT00860717

First Posted

March 11, 2009

Last Updated

December 12, 2009

Sponsor

Para Federal University

1. Study Identification

Unique Protocol Identification Number

NCT00860717

Brief Title

The Use of Low Level Laser Therapy for Wound Healing in Leprosy Patients

Official Title

Clinic-Epidemiological Evaluation of Ulcers in Leprosy Patients and the Use of Low Level Laser Therapy: a Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Para Federal University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Neuropathic ulcers are common sequelae of leprosy. The objectives of this study are to analyze the clinic-epidemiological characteristics of patients attended at one specialized dressing service from a leprosy-endemic region of the Brazilian Amazon and to evaluate the effect of Low Level Laser Therapy on wound healing of these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leprosy

Keywords

Leprosy, Ulcers, Laser

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Arm Title

Arm Type

Experimental

Arm Description

Subjects from the arm number 2 received low level laser therapy 3 times per week for 12 weeks, in addition to the same treatment as patients from the arm number 1.

Intervention Type

Procedure

Intervention Name(s)

Routine treatment

Intervention Description

Subjects from the Control Group received routine treatment, including daily simple dressings with sterile gauze after wound cleaning with a 0.9% physiologic solution, use of 1% hydrophilic silver sulfadiazine cream (Prati Donaduzzi Laboratory, Toledo, Brazil) and orientation about the use of adapted footwear, self-care and the prevention of disabilities. Surgical debridement was done whenever indicated by nursing or orthopedic services from UREMC.

Intervention Type

Radiation

Intervention Name(s)

Low level laser therapy (LLLT)

Other Intervention Name(s)

LLLT, Cold laser, LILT

Intervention Description

The LLLT equipment was an indium-gallium-aluminnium-phosphide (InGaAlP) semiconductor laser with a maximum output power of 40 mW, continuous radiation emission of visible red light with 660 nm wavelength (+/- 10 nm) and a spot area of 0.04 cm². The energy density used was 4 J per point in the wound edges and 2 J/cm² in the wound bed with a power density of 1 W/cm2. Wound beds were irradiated using a scanning technique with no direct contact.

Primary Outcome Measure Information:

Title

Wound healing

Time Frame

Biweekly until the end of the 12 week treatment period.

Secondary Outcome Measure Information:

Title

Ulcer surface area, depth and PUSH tool score.

Time Frame

Biweekly until the end of the 12 week treatment period or until complete cicatrization of the treated ulcer.

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: presented with neuropathic ulcer attended at least 3 weekly appointments at the dressing service of UREMC completed specific multi-drug therapy for M. leprae gave written informed consent to participate in the study Exclusion Criteria: clinically detectable infection in the ulcer use of drugs, like corticosteroids that could interfere with the wound healing process use of special dressings like hydrocolloid, calcium alginate, activated carbon or any kind of therapeutic procedure different from that used routinely for both groups of study non-attendance to therapeutic program (six sequential times or nine intercalated) pregnancy discomfort during treatment procedure

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claudio G Salgado, Dr

Organizational Affiliation

Federal University of Pará

Official's Role

Study Director

Facility Information:

Facility Name

Dr. Marcello Candia Reference Unit in Sanitary Dermatology of the State of Pará in Brazil (UREMC)

City

Marituba

State/Province

Pará

ZIP/Postal Code

67200-000

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

10796615

Citation

Flemming K, Cullum N. Laser therapy for venous leg ulcers. Cochrane Database Syst Rev. 2000;(2):CD001182. doi: 10.1002/14651858.CD001182.

Results Reference

background

PubMed Identifier

15496990

Citation

Hopkins JT, McLoda TA, Seegmiller JG, David Baxter G. Low-Level Laser Therapy Facilitates Superficial Wound Healing in Humans: A Triple-Blind, Sham-Controlled Study. J Athl Train. 2004 Sep;39(3):223-229.

Results Reference

background

PubMed Identifier

10721863

Citation

Schindl A, Schindl M, Pernerstorfer-Schon H, Mossbacher U, Schindl L. Low intensity laser irradiation in the treatment of recalcitrant radiation ulcers in patients with breast cancer--long-term results of 3 cases. Photodermatol Photoimmunol Photomed. 2000 Feb;16(1):34-7. doi: 10.1034/j.1600-0781.2000.160109.x.

Results Reference

background

PubMed Identifier

12928815

Citation

Lucas C, van Gemert MJ, de Haan RJ. Efficacy of low-level laser therapy in the management of stage III decubitus ulcers: a prospective, observer-blinded multicentre randomised clinical trial. Lasers Med Sci. 2003;18(2):72-7. doi: 10.1007/s10103-003-0259-5.

Results Reference

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PubMed Identifier

12376047

Citation

Franek A, Krol P, Kucharzewski M. Does low output laser stimulation enhance the healing of crural ulceration? Some critical remarks. Med Eng Phys. 2002 Nov;24(9):607-15. doi: 10.1016/s1350-4533(02)00112-1.

Results Reference

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PubMed Identifier

11169174

Citation

Schubert V. Effects of phototherapy on pressure ulcer healing in elderly patients after a falling trauma. A prospective, randomized, controlled study. Photodermatol Photoimmunol Photomed. 2001 Feb;17(1):32-8. doi: 10.1034/j.1600-0781.2001.017001032.x.

Results Reference

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PubMed Identifier

12355572

Citation

Pereira AN, Eduardo Cde P, Matson E, Marques MM. Effect of low-power laser irradiation on cell growth and procollagen synthesis of cultured fibroblasts. Lasers Surg Med. 2002;31(4):263-7. doi: 10.1002/lsm.10107.

Results Reference

background

PubMed Identifier

20698989

Citation

Barreto JG, Salgado CG. Clinic-epidemiological evaluation of ulcers in patients with leprosy sequelae and the effect of low level laser therapy on wound healing: a randomized clinical trial. BMC Infect Dis. 2010 Aug 10;10:237. doi: 10.1186/1471-2334-10-237.

Results Reference

derived

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The Use of Low Level Laser Therapy for Wound Healing in Leprosy Patients

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